Midatech Pharma (LON:MTPH Nasdaq:MTP) is set to start manufacturing sustained release products from its upgraded facility in Bilbao, Spain after the initial scale up and regulatory inspection went smoothly.
A formal sustained release sterile manufacturing licence will be granted by the Spanish authorities upon completion of final process validation, which is currently underway said MIdatech.
Midatech has two drug delivery platforms – carbohydrate-coated gold nano-particles and its sustained release system.
The Bilbao facility currently produces all Midatech's gold nanoparticle (GNP) products, but will now add the Sustained Release (Q-Sphera) products, at scale, as well.
Jim Phillips, Midatech Pharma’s chief executive, said: “Manufacturing our GNP and sustained release technologies in Bilbao allows us to control the process without being reliant on an external manufacturer, and all the investment, intellectual property and expertise will therefore be retained in-house.
“Furthermore, there will be significant cost efficiencies rather than outsourcing the manufacturing process to a third-party. This facility will provide for our requirements through to product launch, following which further scale up is planned to cover commercial supplies."
The first sustained release product will be Q-Octreotide (MTD201), an in-development programme for the treatment of acromegaly and carcinoid syndrome, which is planned to commence a Phase I study and follow-on regulatory program later in 2017, with anticipated approval and launch expected in 2018/19.